MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Insufficient Information (4580)

Event Type  Injury  

Event Description

This ruby study subject in this case developed a fever following vacuum-induced hemorrhage control system (jada) removal.The patient received antibiotics for treatment and the fever resolved.The subject of this report is a 22-year-old woman, race reported as white, first pregnancy with gestational hypertension during this pregnancy as significant medical history.On (b)(6) 2021, she presented in spontaneous labor at 35 weeks.On admission, her height was noted as 160 cm, weight 82 kg, body mass index (bmi) 32.03 (units unspecified), and hemoglobin (hgb) 10.4 g/dl.Her hgb at discharge was noted at 8.3 g/dl.She received epidural anesthesia for vaginal delivery of twin infants (baby a 2070 g, baby b 2120 g) and fours of oxytocin at delivery of the placenta.The subject was noted to have postpartum hemorrhage (pph) related to uterine atony after her delivery.The crf noted "unknown" if there was lower uterine segment (lus) bleeding involved in this event for the question asking about lus involvement.Prior to vacuum-induced hemorrhage control system (jada) insertion, this subject received misoprostol and methylergometrine maleate (methergine) (1 dose).The cumulative blood loss prior to vacuum-induced hemorrhage control system (jada) insertion was noted as unknown.Vacuum-induced hemorrhage control system (jada) treatment was initiated on (b)(6) 2022, one hour after delivery of the placenta.The total in-dwelling time for vacuum-induced hemorrhage control system (jada) was 1.5 hours and the total amount of blood collected in the canister during vacuum-induced hemorrhage control system (jada) treatment was documented as unknown.The patient received two units of red blood cells after vacuum-induced hemorrhage control system (jada) treatment.The total blood loss for this case was 1125 ml.The patient received intrapartum antibiotics for group b streptococcus and postpartum antibiotic (piperacillin sodium, tazobactam sodium (zosyn)) was administered with the indication of "vacuum-induced hemorrhage control system (jada) use".A note on the ruby crf stated, "patient with fever overnight following vacuum-induced hemorrhage control system (jada) removal." to the question on the report asking, "did the patient experience a device or procedure related ae?", the answer was checked "yes".And "did the patient experience an sae, related or unrelated?", the answer was checked "no".The patient developed a fever on (b)(6) 2022, antibiotics were given, and the fever resolved on (b)(6) 2022.The site documented this as "not an sae" and as "mild" and "possibly related" to the vacuum-induced hemorrhage control system (jada) device or procedure.The 'type of reportable event' was reported as 'serious injury'.Other adverse event product problem codes included: (b)(4).

Manufacturer Narrative

Based on the overall information currently available for this report, a possible contributing or causal role of the vacuum-induced hemorrhage control system (jada) system for the need of additional treatments (antibiotics and blood products) to preclude permanent body damage/impairment cannot be excluded.Per the vacuum-induced hemorrhage control system (jada) system ifu, "signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (pph)/abnormal postpartum uterine bleeding." and "vacuum-induced hemorrhage control system (jada) is not a substitute for surgical management and fluid resuscitation of life-threatening pph/abnormal postpartum uterine bleeding." out of an abundance of caution, the company will report this case as a serious injury mdr.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park; CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park; CA 94025
• Manufacturer Contact: 3495 edison way; menlo park
• MDR Report Key: 15000085
• MDR Text Key: 295783244
• Report Number: 3017425145-2022-00107
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA1001
• Device Catalogue Number: JADA1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANTIBIOTICS; INTRAPARTUM ANTIBIOTICS; METHYLERGOMETRINE MALEATE (METHERGINE); MISOPROSTOL; OXYTOCIN; PIPERACILLIN SODIUM; POSTPARTUM ANTIBIOTIC; TAZOBACTAM SODIUM (ZOSYN)
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White